Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

NCT ID: NCT03535857

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2023-09-08

Brief Summary

This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Detailed Description

Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Conditions

Overactive Bladder Syndrome; Urinary Incontinence, Urge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unilateral PTNS

34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Group Type: ACTIVE_COMPARATOR

PTNS

Intervention Type: DEVICE

Use of PTNS on the ankle for 30 minutes

Bilateral PTNS

34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Group Type: EXPERIMENTAL

PTNS

Intervention Type: DEVICE

Use of PTNS on the ankle for 30 minutes

Interventions

PTNS

Use of PTNS on the ankle for 30 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy

2. Patients who consent to participate in the study

3. Patients on pharmacologic therapy at the time of recruitment can continue their treatment

Exclusion Criteria

1. Pregnant patients

2. Patients with pacemakers of implantable defibrillators

3. Patients with neurogenic bladder

4. Patients who have received Botox or have an implant for sacral nerve stimulation

5. Patients with uncontrolled bleeding disorder

6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gnankang Sarah Napoe

OTHER

Sponsor Role: lead

Responsible Party

Gnankang Sarah Napoe

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

G. Sarah Napoe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Kyle Wohlrab, MD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

Gnankang Sarah Napoe

Pittsburgh, Pennsylvania, United States

WIHRI

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19100230

Identifier Type: -

Identifier Source: org_study_id